Extension Study Of Tanezumab In Osteoarthritis

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00809783
First received: December 16, 2008
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab


Condition Intervention Phase
Osteoarthritis
Biological: tanezumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Long Term Study Of The Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee Or Hip

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Hematology [ Time Frame: 112 weeks ] [ Designated as safety issue: Yes ]
  • Electrocardiogram [ Time Frame: 112 weeks ] [ Designated as safety issue: Yes ]
  • Clinical Chemistry [ Time Frame: 112 weeks ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: 112 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Womac Pain [ Time Frame: 112 weeks ] [ Designated as safety issue: No ]
  • Womac Physical Function [ Time Frame: 112 weeks ] [ Designated as safety issue: No ]
  • Womac Stiffness [ Time Frame: 112 weeks ] [ Designated as safety issue: No ]

Enrollment: 2147
Study Start Date: February 2009
Study Completion Date: June 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tanezumab 10 mg
Tanezumab 10 mg
Biological: tanezumab
Tanezumab 10 mg
Other Name: RN624
Experimental: Tanezumab 5 mg
Tanezumab 5 mg
Biological: tanezumab
Tanezumab 5 mg
Other Name: RN624
Experimental: Tanezumab 2.5 mg
Tanezumab 2.5 mg
Biological: tanezumab
Tanezumab 2.5 mg
Other Name: RN624

Detailed Description:

This study was terminated on 27 October 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have participated in previous (specific) Phase 3 trials of Tanezumab in osteoarthritis

Exclusion Criteria:

  • Willing to comply with scheduled visits and treatment plan Is medically fit to participate in the trial in the judgement of the Investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809783

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00809783     History of Changes
Other Study ID Numbers: A4091016
Study First Received: December 16, 2008
Last Updated: November 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Tanezumab OA arthritis

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014